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Insufficient funds.
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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Ruijin Hospital | OTHER |
| Shanghai Mental Health Center | OTHER |
| Indiana University |
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To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture group | Experimental | Receiving acupuncture and moxibustion |
|
| sham acupuncture group | Sham Comparator | Receiving sham acupuncture and sham moxibustion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Fatigue Inventory (BFI-C) | The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Fatigue Inventory (BFI-C) | The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90. | Week 24,52 |
| The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huangan Wu, MD, PhD | Shanghai Research Institute of Acupuncture and Meridian | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Research Institute of Acupuncture and Meridian | Shanghai | 200030 | China | |||
| Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| OTHER |
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|
| Sham acupuncture | Other | Patients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. Same Hwato acupuncture device was used to blind the subjects, but do not puncturing into the skin and do not have the deqi sensation. The surface temperature of acupoints was maintained at 37℃± 1℃ for moxibustion. |
|
The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52.
| Week 12, 24,52 |
| Crohn's disease activity index (CDAI)score | The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit. | Week 12, 24,36,48,52 |
| Inflammatory bowel disease questionnaire (IBDQ) | The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224. | Week 12, 24 and 52 |
| Hospital anxiety and depression scale (HADS) | The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21. | Week 12, 24 and 52 |
| Patient Health Questionnaire Depression Scale (PHQ-9) | The mean change in PHQ-9 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 27. | Week 12, 24 and 52 |
| Generalized Anxiety Disorder (GAD-7) | The mean change in gad-7 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21. | Week 12, 24 and 52 |
| The proportion of recurrences | Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition. | Week 52 |
| Brain functional and structural changes | measured by functional MRI | Week 12 |
| Colonoscopy or small bowel MR evaluation | measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score) | Week 52 |
| Laboratory tests | Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count (PLT) | Week 12, 24, 36, and 52 |
| Shanghai |
| 200437 |
| China |